Caregiver Involvement for Underage Alcohol Use

Recruiting at 1 trial location

Overseen By Zachary Adams, PhD, HSPP

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 months

615 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to involve caregivers in reducing alcohol use among teens with mild alcohol use disorder (AUD). Teens will participate in one of three approaches: attending sessions alone (Teen Intervene - Adolescent Only), attending with a caregiver session (Teen Intervene with Caregiver Session), or having the caregiver use an online support tool (Family Check Up). The goal is to determine which method best helps teens reduce alcohol use and improve other areas, such as well-being. Teens aged 12-17 with mild to moderate alcohol or other substance use issues who speak English may be suitable for this trial. As an unphased trial, this study provides a unique opportunity for teens and their caregivers to explore innovative support methods for enhancing well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these interventions are safe for adolescents with mild alcohol use disorder?

Research shows that programs like Teen Intervene are generally well-received by teenagers. Studies have found that programs focusing on the individual, such as the Teen Intervene - Adolescent Only option, effectively help teens reduce alcohol use. These programs work directly with the teen without requiring family involvement and have successfully encouraged behavior change.

When parents participate, as in the Teen Intervene with Caregiver Session, results are mixed. Some research does not show a clear reduction in alcohol use with family involvement, but it suggests that involving parents can lead to stricter rules about underage drinking.

For the Teen Intervene - Online Caregiver Support Tool, which provides parents with online resources, some evidence indicates that improving parenting skills can help reduce substance use in teens. However, the specific impact on alcohol use remains less certain.

Overall, these programs are considered safe, with no major negative effects reported in studies. The aim is to help teens adopt healthier behaviors without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore new ways to involve caregivers in tackling underage alcohol use. Unlike traditional methods that often focus solely on the adolescent, one treatment arm includes a session just for caregivers, helping them learn strategies to support their teens. Another approach provides caregivers with an online tool, offering flexible, convenient support. These unique elements aim to enhance the effectiveness of interventions by fostering a supportive home environment, potentially leading to better outcomes for teens struggling with alcohol use.

What evidence suggests that this trial's treatments could be effective for reducing alcohol use among adolescents with mild AUD?

Research shows that early intervention for teens using substances, such as the Teen Intervene program, can effectively reduce use and improve behavior. In this trial, some participants will receive the Teen Intervene program focusing solely on the individual, which studies have found often significantly reduces alcohol use among teens. Other participants will have caregivers involved, either through a single session or an online support tool. This involvement can enhance the program's effectiveness by improving communication and setting rules about alcohol use. Research on programs involving parents suggests that when parents set stricter rules about underage drinking, it helps reduce risky behaviors. Overall, the Teen Intervene program, with or without caregiver involvement, shows promise for treating mild alcohol use issues in teens by using early intervention strategies and involving families. ^{2 3 6 7 8}

Who Is on the Research Team?

Zachary Adams, PhD, HSPP

Principal Investigator

Indiana University

Tamika Zapolski, PhD, HSPP

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for U.S. teens aged 12-17 who have mild to moderate alcohol use problems, as determined by their primary care provider or clinical assessments. Participants must be fluent in English and are willing to undergo brief interventions aimed at reducing alcohol consumption.

Inclusion Criteria

I am between 12 and 17 years old.

Mild to moderate severity for alcohol use (based on standardized surveys from their primary care provider or clinical indication)

English language fluency

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Teen Intervene brief intervention with varying levels of caregiver involvement

6 months

Multiple sessions over 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3, 6, and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Family Check Up
• Teen Intervene - Adolescent Only
• Teen Intervene with Caregiver Session

Trial Overview The study tests three approaches: Teen Intervene without caregiver involvement, Teen Intervene with a live session including the caregiver, and Family Check Up which is an online program for caregivers. The goal is to find out which method best reduces teen drinking.

How Is the Trial Designed?

Group I: Teen Intervene - Online Caregiver Support Tool Experimental Treatment 1 Intervention

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in two Teen Intervene sessions. Caregiver(s) will be provided with an online tool (Family Checkup Online) that addresses parenting strategies to support their youth.

Group II: Teen Intervene - Caregiver Involvement Experimental Treatment 1 Intervention

The youth will participate in two Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session.

Group III: Teen Intervene - Adolescent Only Active Control 1 Intervention

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in manual-standardized Teen Intervene sessions.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3538561/

Effectiveness of early interventions for substance-using ... Early interventions for adolescent substance use do hold benefits for reducing substance use and associated behavioural outcomes.

2. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/382685

Interventions for Reducing Adolescent Alcohol Abuse Treatments for adolescent substance abuse appear to be effective in reducing alcohol use. Individual-only interventions had larger effect sizes than family- ...

3. publications.aap.org publications.aap.org/pediatrics/article/144/2/e20183014/38537/Understanding-Which-Teenagers-Benefit-Most-From-a

Understanding Which Teenagers Benefit Most From a Brief ... A 15-minute intervention in PC can benefit adolescents with more severe alcohol and marijuana use 1 year later compared with UC.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0955395921000128

Brief interventions to prevent excessive alcohol use in ... This trial found no evidence that PFBA with or without eBI was more effective than screening alone in reducing or delaying alcohol consumption.

5. nasadad.org nasadad.org/wp-content/uploads/2024/06/Hilton-Early-Intervention-Lit-Rev-10.15.pdf

Early Intervention Services for Adolescents and The outcomes measured at baseline and 6-month follow-up included past- month days drinking, times intoxicated, and drug use. Brief intervention was provided to.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6601658/

Interventions for Alcohol Use and Alcohol Use Disorders in ... This article examines both environmental- and individual-level approaches to underage drinking prevention, including school- and family-based programs, and ...

7. publications.aap.org publications.aap.org/pediatrics/article/144/1/e20191356/37084/Alcohol-Use-by-Youth

Alcohol Use by Youth | Pediatrics The younger youth initiate alcohol use, the greater their risk of developing an alcohol use disorder (AUD) later in life.

8. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/1747-597X-9-48

Effectiveness of school-based preventive interventions on ... The purpose of this study was to assess the effectiveness of universal school-based prevention programs on alcohol use among adolescents by using meta-analytic ...